Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-813-2 | CAS number: 74-83-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-1 (Chronic Toxicity)
- Deviations:
- yes
- Principles of method if other than guideline:
- This study appears to conform to EU test method B31 with the following deviations
1. This study was carried out in the dog as opposed to the preferred species mentioned in the guidance, i.e. the rat. However the guidance does state that other species (rodent or non-rodent) may be used based on the results of previously conducted studies.
2. This study is described as a safety study as opposed to a toxicity study, with the highest dose selected for US registration of Methyl Bromide following specific discussions with the US EPA, as opposed to being selected as the dose most likely to ensure toxic effects.
3. Clinical observations should be carried out once daily as opposed to weekly.
4. Urinalysis should be carried out at the same time intervals as haematological analysis. However in this study urinalysis was carried out at 6 months and prior to study termination.
This study contains one major deviation in that the highest dose level was not selected as the most likely to ensure toxic effects. However it is felt that the study contains scientifically valid information. - GLP compliance:
- yes
Test material
- Reference substance name:
- 74-83-2
- IUPAC Name:
- 74-83-2
- Reference substance name:
- Bromomethane
- EC Number:
- 200-813-2
- EC Name:
- Bromomethane
- Cas Number:
- 74-83-9
- Molecular formula:
- CH3Br
- IUPAC Name:
- bromomethane
- Details on test material:
- Methyl Bromide: batch no.: SLV; purity: 100%
Constituent 1
Constituent 2
Test animals
- Species:
- dog
Administration / exposure
- Details on study design:
- 3 groups of 4 dogs per sex were dosed 0, 0.5 and 1.5 ppm (equivalent to 0, 0.06 and 0.13 mg/kg day) Methyl Bromide fumigated food and 1 group of 8 dogs per sex was dosed 5.0 ppm (equivalent to 0.27 mg.kg day) Methyl Bromide fumigated food which was presented to dogs for a one hour feeding period, 5 days per week for a period of 12 months.
Clinical observations were made at regular intervals, body weights and food consumption was measured. Haematological analysis, serum chemistry analysis and urinalysis were carried out. Ophthalmological examinations were also conducted pretest and at selected intervals during the treatment period. Macroscopic and microscopic examinations were carried out and specific organs were weighted at study termination.
Results and discussion
Results of examinations
- Details on results:
- Mortality and physical observations
There were no unscheduled deaths or Methyl Bromide related physical observations seen during the course of this study.
Ophthalmoscopic examinations
There was no indication of any Methyl Bromide-related ocular disease
Body weights and food consumption
There were no Methyl Bromide-related effect on body weight, body weight gain or food consumption
Methyl Bromide intake information
T90 data indicated that the dogs had consumed about 75% of the total feed that they were going to eat during the first 30 minutes. The Methyl Bromide residual data indicated that the Methyl Bromide residual was about 50% of its T60 value at T90. An estimate of actual Methyl Bromide intake, or dose, was calculated based upon a time-weighted average. (TWA). For the highest dose group the target Methyl Bromide TWA intake was 0.125 mg/kg/day (5 ppm). However the actual Methyl Bromide TWA intake was 0.27 mg/kg/day.
Haematolology
There was no toxicologically significant effect on any haematology parameter produced by exposure to Methyl Bromide.
Clinical chemistry
There was no toxicologically significant effect on any clinical chemistry parameter produced by exposure to Methyl Bromide.
Urinalysis
There was no Methyl Bromide related-effect on any parameter seen in the urinalysis.
Terminal organ and body weights/body weight and organ/brain weight ratios
There was no Methyl Bromide-related effect seen on the terminal absolute or relative organ weights.
Macroscopic findings
A small number of macroscopic post mortem changes were noted in various organs and tissues, bearing no obvious relationship to the exposure of the animals to Methyl Bromide.
Microscopic findings
The results of microscopic examination of selected organs and tissues revealed no morphological evidence of Methyl Bromide related toxicity.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- > 0.27 mg/kg bw (total dose)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Fumigation of feed with Methyl Bromide, which led to Methyl Bromide averages intakes of up to 0.27 mg/kg/day for a year had no effect on any parameter measured. Under the conditions of this study, the NOEL for Methyl Bromide fumigated feed in dogs would be greater than 0.27 mg/kg/day of Methyl Bromide.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.